Chemist jobs in Arecibo, PR - 16 jobs

Job Description Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position: Lab Tech II Position Description The selected candidate will perform routine analytical testing to support on-site wastewater treatment operations and ensure compliance with local and state regulatory requirements. This role requires the ability to interpret analytical data, coordinate sample testing, and accurately document results using computerized systems. The position is based in laboratory areas and involves close collaboration within a team environment. Key Responsibilities Perform routine analytical testing in support of on-site wastewater treatment operations. Ensure compliance with local and state environmental requirements. Coordinate sample testing activities and input analytical data into computer spreadsheets and laboratory systems. Review and verify analytical data related to finished products and raw materials. Operate analytical laboratory equipment, including analytical balances, total carbon analyzers, spectrophotometers, and pH meters. Interpret test results and support basic data analysis and troubleshooting. Follow laboratory safety, quality, and documentation standards. Support increased workload and volume demands as required by business needs. Required Qualifications Bachelor's degree or Associate degree in Chemistry or a related chemical field. Minimum of 2 years of experience in a pharmaceutical chemical laboratory environment. Strong laboratory skills; experience in wastewater testing is preferred but not required. Experience reviewing analytical data for raw materials and finished products. Proficiency in operating analytical laboratory equipment. Ability to understand, read, and write English. Strong problem-solving skills and attention to detail. Computer proficiency, including data entry and spreadsheet use. Effective verbal and written communication skills. Background in chemical analysis (microbiology experience not required). Work Environment & Schedule Work environment: Laboratory areas; team-based setting. Shift: Primarily second shift; must be flexible to work first or second shift as business needs vary. Schedule may vary from Monday-Friday or Tuesday-Saturday. Overtime is required based on business needs, including approximately one weekend per month. Additional Information On-site position; remote work is not available. Relocation assistance is not provided; candidates must already be local. No travel required. No work with toxins. Interview process: One interview round conducted via Microsoft Teams.

For Compliance services in the Quality area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree in Chemical Engineering, Biology, or Microbiology Science & six (6) years of experience in the Pharmaceutical Manufacturing industry. Bilingual (English & Spanish) Shifts: 12-hour rotative, and according to business needs. Weeks 1 & 3: Monday, Thursday, Friday, and Saturday. Weeks 2 & 4: Tuesday, Wednesday, and Sunday. Experience in: Quality Assurance & cGMP Compliance GMP Document Approval Investigation & Root Cause Analysis Cross-Functional Collaboration The Personality Part: Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one of your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, consistently delivering top-quality results. Are you ready to Be The Piece? AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Interfaces directly with manufacturing and/or support areas operations to ensure that appropriate procedures are in place, through the execution of thorough reviews of procedures against practice. Leads and participates in the critical review of all documents associated with the manufacturing and/or support areas operations, release, packaging, and relevant activities in the operations areas. Ensures that deviations in documentation related to OOS or process parameters outside filing or validation are investigated and resolved by thoroughly reviewing timely corrective actions. Provides key technical guidance and oversight to manufacturing and/or support area operations (Sterile, Non-Sterile, QC Laboratories, Warehouse, Engineering, Supply Chain, MS&T, IM, among others) to ensure appropriate cGMPs are in place through quarterly, monthly, weekly, or daily operations audits, as applicable. Ensures compliance with all procedures (SOP's) to avoid potential regulatory and compliance issues, including GDP and electronic systems compliance. Provides scientific input into investigation management to ensure root causes and CAPAs are aligned with the opportunities identified, enabling a systematic approach. Supports actively the investigation processes in manufacturing areas (Sterile and Non Sterile) and support areas such as Warehouse, QC laboratories, IT, MS&T, facilities, and utilities, providing coaching from a quality perspective. Provides guidance on gaps identified from the review and actively participates in determining potential remediation activities. Supports risk analysis process when required per procedures. Evaluates product impact and provides lot disposition recommendations when an investigation is completed as needed. Manages audit observation, investigations, change control, and CAPAs records in the applicable QMS on timely manner. Provides technical guidance and quality assurance support in the transfer of new products and processes to maintain quality standards. Participates in Manufacturing Alignment Teams (MAT) and Project Alignment Teams (PAT), department staff, planning, and change control board meetings, as required. Evaluates documentation compliance, including data GDP compliance and electronic system data compliance, and its overall management requirements for all manufacturing and support areas, including QC laboratories, such as CR's, SOP's, BR's, Forms, Logbooks, BOM's, WPP's, qualification and validation Protocols, according to government regulations and clients Policies. Provides support to the area QA Leader during the budget preparation activities. Evaluates department performance indicators and develops the appropriate corrective actions if needed Assists management during internal and regulatory agencies inspections (FDA, DEA, MCA, etc). Develops sampling plans based on acceptance quality level criteria when additional or special testing is required. Performs trend analysis to provide recommendations in order to improve the process and /or the product quality. Supports Media Fill activities to ensure that both typical and atypical interventions are performed as established. Supports the Annual Product Review elements for Quality events of manufacturing and environmental monitoring. Evaluates and approves the instrumentation and equipment calibration records and critical area engineering drawings. Reviews and approves equipment, utilities, and facilities qualification, and system life-cycle documentation. Reviews and approves all process, product, and computer systems validation protocols and reports, change control documentation, redressing/reprocessing / rework operations, investigation reports related to manufacturing process and microbiology laboratory, and Annual Product Quality Review (APQRs) elements. Approves or rejects procedures impacting drug products, raw material, or packaging components. Verifies compliance with clients' policies and Guidelines. Participates as quality representative or liaison in site projects Performs pre-operational review form approval in the manufacturing and packaging area. Performs shop floor walk-through audits and challenges adherence to area procedures, providing coaching and Quality Support in alignment with the business unit to optimize compliance and effectiveness. Verifies consistency with other site procedures and/or specifications. Reviews and approves investigations related to process, products, utilities, microbiology laboratory, and calibrations. Approves Corrective and Preventive actions (CAPAs). Approves or rejects specifications impacting drug products, raw material, or packaging components. Ensures effective systems for equipment maintenance and calibration, and approves calibration requests. Ensures the designation and monitoring of storage conditions for quarantine materials and products. Reviews and approves procedures for processes, products, utilities, and laboratories. Maintains management informed (via frequent written reports) of any problem that might affect the quality and/or timely release of materials WHO WE ARE: We are a Service Provider company different from the rest. We pride ourselves on how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities, and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented, and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device, and Manufacturing industry clients with top-notch quality talent. We're FITS! Are you the Next Piece?

**At Kelly** ** ** **Science, Engineering, Technology & Telecom (SETT), we're passionate about helping you find a job that works for you. How about this one?** We're seeking for Laboratory Technicians to work in the north region, in PR. With us, it's all about finding the job that's just right. **This job might be an outstanding fit if you have:** + Bachelor of Science in Chemistry. + 2+ years of directly related experience. Experience in HPLC, GC, UV conductivity meter, pH meter, preparation of laboratory solutions, etc. + General knowledge of research practices and methods. + Bilingual: Spanish & English- verbal and writing skills. + Computer skills: MS Word & Excel. + Available to work all shifts (1st, 2nd, 3rd, 12hrs, rotative shifts) including weekends and holidays. **What happens next** Once you apply, you'll proceed to next steps if your skills and experience look like a good fit. But don't worry-even if this position doesn't work out, you're still in our network. That means all our recruiters will have access to your profile, expanding your opportunities even more. Helping you discover what's next in your career is what we're all about, so let's get to work. Apply today! As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (********************************************************************* for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community. Why Kelly Science & Clinical? Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed. About Kelly Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year. Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

**Intended for students graduating with their Doctorate degree by, or have graduated within, 12 months of cohort start date in June/July 2026.** **The Program:** Our future success depends on hiring world-class, early in career talent who are looking to power next-generation services and solutions. We are hiring students with a diverse set of skills and experiences to work in and across teams. Our program is intended to enhance your overall learning experience, help build your network, and accelerate your opportunity to make an impact. **The Team:** Oracle Health & Analytics is a new line of business that aims to leverage our expertise in IaaS and SaaS to transform the healthcare industry, provide patient-centric care, and make the best clinical tools available around the world (*********************************************** We are looking for the best and brightest technologists as we build the next generation of health platforms that will change the industry. This is a greenfield effort with an entrepreneurial spirit that promotes an energetic and creative environment. We like to move fast and innovate, and we want your help to make it a world-class engineering team that makes a significant impact. Analytics Cloud is also a business platform that delivers a full range of analytic and reporting capabilities. Our Business Intelligence platform of products provides enterprise-class level performance, security, scalability and manageability apart from the very sophisticated and innovative features in core analytics. The BI platform is world-class federated database. It enables business applications to query data from multiple heterogeneous systems and perform advanced business analytics. This platform enables companies to quickly and accurately gain a holistic view of their performance, as well as optimize their decision-making process. We have successfully differentiated ourselves from the competition by providing unparalleled breadth and depth in our features. **The Company:** Oracle is the world's leading provider of business software. With a presence in over 175 countries, we are one of the biggest technology companies on the planet. We're using innovative emerging technologies to tackle real-world problems today. From advancing energy efficiency to reimagining online commerce, the work we do is not only transforming the world of business-it's helping advance governments, power nonprofits, and giving billions of people the tools they need to outpace change. For more information about Oracle (NYSE:ORCL), visit us at oracle.com (********************************** . **Responsibilities** **What You'll Do:** As an Applied Scientist within Oracle Health and Analytics, you will be leading the effort of building distributed, scalable, high-performance AI model training and serving systems in partnership with our applied scientists and software engineers. You will dive deep into model structure to optimize model performance and scalability. You will build state of art systems with cutting-edge technologies in this fast evolving area. you will play a key role in shaping the future of Oracle, with an emphasis on AI and Machine Learning. **What You'll Bring: (Objective Minimum Qualifications)** + Have a **PhD** in Computer Science, Mathematics, Statistics, Physics, Linguistics or a related field with a dissertation, thesis or final project centered in Machine Learning and Deep Learning) by **July 2026.** + Demonstrated experience in designing and implementing scalable AI models for production. + Deep technical understanding of Machine Learning, Gen AI, Data Science, and Deep Learning architectures. + Hands-on experience with emerging LLM frameworks and plugins, such as LangChain, LlamaIndex, VectorStores and Retrievers, LLM Cache, LLMOps (MLFlow), LMQL, Guidance, etc. + Commitment to staying up-to-date with the field and applying academic advances to solve complex business problems, and bringing them into production. + Strong publication record, including as a lead author or reviewer, in top-tier journals or conferences + Reside in the United States and/or attend a university in the US. + Able to obtain work authorization in the US in **2026.** **Preferred Qualifications:** + Familiarity and experience with the latest advancements in computer vision and multimodal modeling is a plus. + Minimum 3.0 GPA Disclaimer: **Certain US customer or client-facing roles may be required to comply with applicable requirements, such as immunization and occupational health mandates.** **Range and benefit information provided in this posting are specific to the stated locations only** US: Hiring Range in USD from: $97,500 to $199,500 per annum. May be eligible for bonus and equity. Oracle maintains broad salary ranges for its roles in order to account for variations in knowledge, skills, experience, market conditions and locations, as well as reflect Oracle's differing products, industries and lines of business. Candidates are typically placed into the range based on the preceding factors as well as internal peer equity. Oracle US offers a comprehensive benefits package which includes the following: 1. Medical, dental, and vision insurance, including expert medical opinion 2. Short term disability and long term disability 3. Life insurance and AD&D 4. Supplemental life insurance (Employee/Spouse/Child) 5. Health care and dependent care Flexible Spending Accounts 6. Pre-tax commuter and parking benefits 7. 401(k) Savings and Investment Plan with company match 8. Paid time off: Flexible Vacation is provided to all eligible employees assigned to a salaried (non-overtime eligible) position. Accrued Vacation is provided to all other employees eligible for vacation benefits. For employees working at least 35 hours per week, the vacation accrual rate is 13 days annually for the first three years of employment and 18 days annually for subsequent years of employment. Vacation accrual is prorated for employees working between 20 and 34 hours per week. Employees working fewer than 20 hours per week are not eligible for vacation. 9. 11 paid holidays 10. Paid sick leave: 72 hours of paid sick leave upon date of hire. Refreshes each calendar year. Unused balance will carry over each year up to a maximum cap of 112 hours. 11. Paid parental leave 12. Adoption assistance 13. Employee Stock Purchase Plan 14. Financial planning and group legal 15. Voluntary benefits including auto, homeowner and pet insurance The role will generally accept applications for at least three calendar days from the posting date or as long as the job remains posted. Career Level - IC3 **About Us** As a world leader in cloud solutions, Oracle uses tomorrow's technology to tackle today's challenges. We've partnered with industry-leaders in almost every sector-and continue to thrive after 40+ years of change by operating with integrity. We know that true innovation starts when everyone is empowered to contribute. That's why we're committed to growing an inclusive workforce that promotes opportunities for all. Oracle careers open the door to global opportunities where work-life balance flourishes. We offer competitive benefits based on parity and consistency and support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs. We're committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing accommodation-request_************* or by calling *************** in the United States. Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans' status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.

At **Kelly Science, Engineering, Technology & Telecom (SETT** **)** , we're passionate about helping you find a job that works for you. How about this one? We're seeking an **Laboratory Technician** to work with one of our top global biopharmaceutical clients in the **Barceloneta PR** area. With us, it's all about finding the job that's just right Perform laboratory analytical tests on raw materials and finished products following the established parameters (company policies, FDA, cGMP) and applicable regulations without impact to the manufacturing cycle or the laboratory workflow. Follow Good Manufacturing Practices), safety rules, and Good Laboratory Practices (GLP). **Responsibilities:** * Responsible for performing laboratory analytical tests on the raw materials and finished products following the established parameters (Customer policies, FDA, cGMP) and applicable regulations without impact to the manufacturing cycle or the laboratory workflow. * Document The results of the test and analysis performed accurately. * Perform preventive maintenance and standardize the laboratory equipment. * Participate in the implementation of special projects and test method transfers. * Assure that all samples are collected, tested, and authorized as per the schedule and following applicable procedures. **Qualifications** * Associate or Bachelor degree in Science required, with a major in **Chemistry** * A minimum of two years of experience in the pharmaceutical industry or equivalent in an analytical laboratory.. * Availability to work the third shift, ALL Shifts weekends, and holidays according to business needs. As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (********************************************************************* for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community. Why Kelly Science & Clinical? Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed. About Kelly Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year. Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Quality Job Sub Function: Quality Control Job Category: Professional All Job Posting Locations: Gurabo, Puerto Rico, United States of America Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at *******************/innovative-medicine We are searching for the best talent for QC Chemistry Scientist (6 openings) to be located at Gurabo, PR. An internal pre-identified candidate for consideration has been identified. However, all applications will be considered. The QC Chemistry Scientist is responsible for performing and reviewing all chemical and physical testing of raw materials, products and utilities (i.e. water, etc.) according with internal and compendia specifications. Performs investigations when questionable analytical results have been generated Assures the compliance to all quality control policies, procedures and systems to ensure the timely release of high quality product in support of the supply chain process failure to perform his/her functions effectively could result in product recall. You will be responsible for: * Performs all laboratory analysis and activities in accordance with cGMP's practices, internal and external regulations and policies, and consistent with supply chain cycle time goals. Responsible for following laboratory priority report and in-process boards to support manufacturing rhythm wheels and business rules. Complies with all Laboratory Schedules for raw materials and/or drug product testing and special projects. Assures to follow QC initiatives and requirements. * Verifies (Peer Reviewer) documentation of data generated by other QC Scientist in a timely manner and according to specifications. Assures correctness and informs Supervisors and Managers of any deviation encountered for proper investigation and corrective action plan. Maintains all solutions and samples tested until release of lot for any laboratory investigation required. * Operates, with the proper training, all laboratory equipment and instrumentation required for testing such as: UV-Visible spectrophotometers, FTIR, pH meters, viscometers, specific gravity apparatus, analytical balances, polarimeters, GC and HPLC chromatographers, dissolution baths and any other computerized system. * Maintains accurate and neat records of all work performed. Reports results and/or deviations associated in a clear, concise and accurate manner and within the standard time assigned for each material. Limited amount of errors are generated. * Works on special projects such as equipment calibration, process validation and cleaning and method transfers. * Complies with the goals of the quality team and with overall business and process goals. * Maintains the hazardous material storage area in full compliance and optimum housekeeping conditions. Assures all containers and glassware used are properly labeled during usage at all times. Assures proper disposal and reporting to management of any spill deviation encountered related to environmental compliance or safety. * Actively participates in projects, safety and environmental, GMPs, SOPs trainings and others as required and/or special activities that the company promotes to foster employee involvement and their professional development/growth such as: environmental/safety/GMP improvement project to simplify, reduce, minimize or eliminate environmental or compliance aspects at the job area. Qualifications / Requirements: * A minimum of a Bachelor's degree in Chemistry is required. * A minimum of 1 years of work experience is required. * Knowledge of cGMP's and compliance. * Technical knowledge of Chemistry. * Broader knowledge of basic sample preparation techniques. * Broader knowledge of analytical techniques such as HPLC, GC, UV-Visible spectrophotometer, Gravimetric, Volumetric, TOC, FTIR, pH meters, Polarimetry. * Experience working with Wet Chemistry and USP/EP/JP/ChP compendia techniques. * Computer and Software skills. LIMS system basic knowledge. * Understand impact of laboratory performance on supply chain and business results. * Bilingual (English & Spanish). * Technical writing skills. * Problem solving/troubleshooting. * Ability on training colleagues on analytical techniques. * This position may require availability to work the 1st and/or 2nd shifts, including irregular (non-standard) shifts and/or weekends based on business needs. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource. #LI-Onsite Required Skills: Preferred Skills: Analytical Reasoning, Chemical Laboratory, Chemistry, Compliance Management, Continuous Improvement, Controls Compliance, Data Analysis, Execution Focus, Quality Control (QC), Quality Standards, Quality Systems Documentation, Report Writing, Sample Testing, Technical Writing

Validation & Engineering Group, Inc. is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, manufacturing operations among other services. Job Description Development and execution of Laboratory Equipment Validation. Development of Validation Plan, Risk Assessment, IOQ, CSV IOQ, Traceability Matrix, Validation Report, Operational and Administrative SOPs. Execution of related validation protocols. Development of documentation packages for all activities, including: Original format documents, approved document and applicable drawings. Qualifications Bachelor Degree in Chemistry or related discipline Experience developing Validation Plans, Risk Assessments, IOQ, CSV IOQ, Traceability Matrix, Validation Report, Operational and Administrative SOPs. Validation Experience in Computer Systems 21 CFR Part 11 practical knowledge Strong knowledge in GMPs regulations Technical Writing Experience Validation expertise in: Sterilization Kaye Validator & Data loggers Process Validation Equipment Qualification Re-qualification Computer System Validation Additional Information Positions available for Puerto Rico. Only candidates that meet the minimum requirements will be considered. Validation and Engineering Group, Inc. is an Equal Employment Opportunity employer.

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Summary of Role: The consultant will develop and execute Environmental Qualification, Airflow Visualization Study (AVS) and Aseptic Process Simulation (APS) deliverables for operational readiness projects. Responsibilities: Responsible for the Activities before Environmental monitoring performance qualification (EMPQ) execution Responsible for the EMPQ execution & post approval Responsible for the Air Visualization Studies Responsible for the Aseptic Process Simulation Media Fill (MF) Participate in project meetings, as applicable Generate Validation Plan establishing lean strategies, as required. Develop and execute EM PQ, AVS and APS protocols for applicable systems Develop EM PQ, AVS and APS reports for applicable systems Evaluate, coordinate, and execute the required efforts (resources, plant support, equipment, materials, etc.) to support projects deliverables. Comply with projects schedule and escalate any roadblock or issues immediately including proposed mitigation plan. Provide support during documentation transfer to DMS or Quality. Shift: (1st, 2nd, and 3rd Shift) Location: Juncos, PR Education: Bachelor's degree in Engineering or a Scientific field. Preferred Qualifications: 5+ years of experience in a regulated industry. Experience with Environmental monitoring performance qualification (EMPQ) execution Preferred experience with Aseptic Process Simulation Media Fill (MF) Strong knowledge of cGMP/FDA regulations Strong communication skills (oral and written) Ability to organize and manage multiple tasks in a fast-paced environment Attention to detail Demonstrated problem solving and analytical skills This position is for a fixed term contract supporting one of ECHO Consulting Group (a Cencora company) partners on site at their facility. What Cencora offers We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit ************************************** Full time Equal Employment Opportunity Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law. The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call ************ or email ****************. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned Affiliated CompaniesAffiliated Companies: Echo Consulting Group Inc

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position: * Lab Tech II Position Description The selected candidate will perform routine analytical testing to support on-site wastewater treatment operations and ensure compliance with local and state regulatory requirements. This role requires the ability to interpret analytical data, coordinate sample testing, and accurately document results using computerized systems. The position is based in laboratory areas and involves close collaboration within a team environment. Key Responsibilities * Perform routine analytical testing in support of on-site wastewater treatment operations. * Ensure compliance with local and state environmental requirements. * Coordinate sample testing activities and input analytical data into computer spreadsheets and laboratory systems. * Review and verify analytical data related to finished products and raw materials. * Operate analytical laboratory equipment, including analytical balances, total carbon analyzers, spectrophotometers, and pH meters. * Interpret test results and support basic data analysis and troubleshooting. * Follow laboratory safety, quality, and documentation standards. * Support increased workload and volume demands as required by business needs. Required Qualifications * Bachelors degree or Associate degree in Chemistry or a related chemical field. * Minimum of 2 years of experience in a pharmaceutical chemical laboratory environment. * Strong laboratory skills; experience in wastewater testing is preferred but not required. * Experience reviewing analytical data for raw materials and finished products. * Proficiency in operating analytical laboratory equipment. * Ability to understand, read, and write English. * Strong problem-solving skills and attention to detail. * Computer proficiency, including data entry and spreadsheet use. * Effective verbal and written communication skills. * Background in chemical analysis (microbiology experience not required). Work Environment & Schedule * Work environment: Laboratory areas; team-based setting. * Shift: Primarily second shift; must be flexible to work first or second shift as business needs vary. * Schedule may vary from MondayFriday or TuesdaySaturday. * Overtime is required based on business needs, including approximately one weekend per month. Additional Information * On-site position; remote work is not available. * Relocation assistance is not provided; candidates must already be local. * No travel required. * No work with toxins. * Interview process: One interview round conducted via Microsoft Teams. *

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Quality Job Sub Function: Quality Control Job Category: Professional All Job Posting Locations: Gurabo, Puerto Rico, United States of America Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at *******************/innovative-medicine We are searching for the best talent for QC Chemistry Scientist (6 openings) to be located at Gurabo, PR. An internal pre-identified candidate for consideration has been identified. However, all applications will be considered. The QC Chemistry Scientist is responsible for performing and reviewing all chemical and physical testing of raw materials, products and utilities (i.e. water, etc.) according with internal and compendia specifications. Performs investigations when questionable analytical results have been generated Assures the compliance to all quality control policies, procedures and systems to ensure the timely release of high quality product in support of the supply chain process failure to perform his/her functions effectively could result in product recall. You will be responsible for: Performs all laboratory analysis and activities in accordance with cGMP's practices, internal and external regulations and policies, and consistent with supply chain cycle time goals. Responsible for following laboratory priority report and in-process boards to support manufacturing rhythm wheels and business rules. Complies with all Laboratory Schedules for raw materials and/or drug product testing and special projects. Assures to follow QC initiatives and requirements. Verifies (Peer Reviewer) documentation of data generated by other QC Scientist in a timely manner and according to specifications. Assures correctness and informs Supervisors and Managers of any deviation encountered for proper investigation and corrective action plan. Maintains all solutions and samples tested until release of lot for any laboratory investigation required. Operates, with the proper training, all laboratory equipment and instrumentation required for testing such as: UV-Visible spectrophotometers, FTIR, pH meters, viscometers, specific gravity apparatus, analytical balances, polarimeters, GC and HPLC chromatographers, dissolution baths and any other computerized system. Maintains accurate and neat records of all work performed. Reports results and/or deviations associated in a clear, concise and accurate manner and within the standard time assigned for each material. Limited amount of errors are generated. Works on special projects such as equipment calibration, process validation and cleaning and method transfers. Complies with the goals of the quality team and with overall business and process goals. Maintains the hazardous material storage area in full compliance and optimum housekeeping conditions. Assures all containers and glassware used are properly labeled during usage at all times. Assures proper disposal and reporting to management of any spill deviation encountered related to environmental compliance or safety. Actively participates in projects, safety and environmental, GMPs, SOPs trainings and others as required and/or special activities that the company promotes to foster employee involvement and their professional development/growth such as: environmental/safety/GMP improvement project to simplify, reduce, minimize or eliminate environmental or compliance aspects at the job area. Qualifications / Requirements: A minimum of a Bachelor's degree in Chemistry is required. A minimum of 1 years of work experience is required. Knowledge of cGMP's and compliance. Technical knowledge of Chemistry. Broader knowledge of basic sample preparation techniques. Broader knowledge of analytical techniques such as HPLC, GC, UV-Visible spectrophotometer, Gravimetric, Volumetric, TOC, FTIR, pH meters, Polarimetry. Experience working with Wet Chemistry and USP/EP/JP/ChP compendia techniques. Computer and Software skills. LIMS system basic knowledge. Understand impact of laboratory performance on supply chain and business results. Bilingual (English & Spanish). Technical writing skills. Problem solving/troubleshooting. Ability on training colleagues on analytical techniques. This position may require availability to work the 1st and/or 2nd shifts, including irregular (non-standard) shifts and/or weekends based on business needs. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource. #LI-Onsite Required Skills: Preferred Skills: Analytical Reasoning, Chemical Laboratory, Chemistry, Compliance Management, Continuous Improvement, Controls Compliance, Data Analysis, Execution Focus, Quality Control (QC), Quality Standards, Quality Systems Documentation, Report Writing, Sample Testing, Technical Writing

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position: Lab Tech II Position Description The selected candidate will perform routine analytical testing to support on-site wastewater treatment operations and ensure compliance with local and state regulatory requirements. This role requires the ability to interpret analytical data, coordinate sample testing, and accurately document results using computerized systems. The position is based in laboratory areas and involves close collaboration within a team environment. Key Responsibilities Perform routine analytical testing in support of on-site wastewater treatment operations. Ensure compliance with local and state environmental requirements. Coordinate sample testing activities and input analytical data into computer spreadsheets and laboratory systems. Review and verify analytical data related to finished products and raw materials. Operate analytical laboratory equipment, including analytical balances, total carbon analyzers, spectrophotometers, and pH meters. Interpret test results and support basic data analysis and troubleshooting. Follow laboratory safety, quality, and documentation standards. Support increased workload and volume demands as required by business needs. Required Qualifications Bachelor s degree or Associate degree in Chemistry or a related chemical field. Minimum of 2 years of experience in a pharmaceutical chemical laboratory environment. Strong laboratory skills; experience in wastewater testing is preferred but not required. Experience reviewing analytical data for raw materials and finished products. Proficiency in operating analytical laboratory equipment. Ability to understand, read, and write English. Strong problem-solving skills and attention to detail. Computer proficiency, including data entry and spreadsheet use. Effective verbal and written communication skills. Background in chemical analysis (microbiology experience not required). Work Environment & Schedule Work environment: Laboratory areas; team-based setting. Shift: Primarily second shift; must be flexible to work first or second shift as business needs vary. Schedule may vary from Monday Friday or Tuesday Saturday. Overtime is required based on business needs, including approximately one weekend per month. Additional Information On-site position; remote work is not available. Relocation assistance is not provided; candidates must already be local. No travel required. No work with toxins. Interview process: One interview round conducted via Microsoft Teams.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Quality Job Sub Function: Quality Control Job Category: Professional All Job Posting Locations: Gurabo, Puerto Rico, United States of America Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at *******************/innovative-medicine We are searching for the best talent for QC Chemistry Scientist (6 openings) to be located at Gurabo, PR. An internal pre-identified candidate for consideration has been identified. However, all applications will be considered. The QC Chemistry Scientist is responsible for performing and reviewing all chemical and physical testing of raw materials, products and utilities (i.e. water, etc.) according with internal and compendia specifications. Performs investigations when questionable analytical results have been generated Assures the compliance to all quality control policies, procedures and systems to ensure the timely release of high quality product in support of the supply chain process failure to perform his/her functions effectively could result in product recall. You will be responsible for: Performs all laboratory analysis and activities in accordance with cGMP's practices, internal and external regulations and policies, and consistent with supply chain cycle time goals. Responsible for following laboratory priority report and in-process boards to support manufacturing rhythm wheels and business rules. Complies with all Laboratory Schedules for raw materials and/or drug product testing and special projects. Assures to follow QC initiatives and requirements. Verifies (Peer Reviewer) documentation of data generated by other QC Scientist in a timely manner and according to specifications. Assures correctness and informs Supervisors and Managers of any deviation encountered for proper investigation and corrective action plan. Maintains all solutions and samples tested until release of lot for any laboratory investigation required. Operates, with the proper training, all laboratory equipment and instrumentation required for testing such as: UV-Visible spectrophotometers, FTIR, pH meters, viscometers, specific gravity apparatus, analytical balances, polarimeters, GC and HPLC chromatographers, dissolution baths and any other computerized system. Maintains accurate and neat records of all work performed. Reports results and/or deviations associated in a clear, concise and accurate manner and within the standard time assigned for each material. Limited amount of errors are generated. Works on special projects such as equipment calibration, process validation and cleaning and method transfers. Complies with the goals of the quality team and with overall business and process goals. Maintains the hazardous material storage area in full compliance and optimum housekeeping conditions. Assures all containers and glassware used are properly labeled during usage at all times. Assures proper disposal and reporting to management of any spill deviation encountered related to environmental compliance or safety. Actively participates in projects, safety and environmental, GMPs, SOPs trainings and others as required and/or special activities that the company promotes to foster employee involvement and their professional development/growth such as: environmental/safety/GMP improvement project to simplify, reduce, minimize or eliminate environmental or compliance aspects at the job area. Qualifications / Requirements: A minimum of a Bachelor's degree in Chemistry is required. A minimum of 1 years of work experience is required. Knowledge of cGMP's and compliance. Technical knowledge of Chemistry. Broader knowledge of basic sample preparation techniques. Broader knowledge of analytical techniques such as HPLC, GC, UV-Visible spectrophotometer, Gravimetric, Volumetric, TOC, FTIR, pH meters, Polarimetry. Experience working with Wet Chemistry and USP/EP/JP/ChP compendia techniques. Computer and Software skills. LIMS system basic knowledge. Understand impact of laboratory performance on supply chain and business results. Bilingual (English & Spanish). Technical writing skills. Problem solving/troubleshooting. Ability on training colleagues on analytical techniques. This position may require availability to work the 1st and/or 2nd shifts, including irregular (non-standard) shifts and/or weekends based on business needs. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource. #LI-Onsite Required Skills: Preferred Skills: Analytical Reasoning, Chemical Laboratory, Chemistry, Compliance Management, Continuous Improvement, Controls Compliance, Data Analysis, Execution Focus, Quality Control (QC), Quality Standards, Quality Systems Documentation, Report Writing, Sample Testing, Technical Writing

**At Kelly** ** ** **Science, Engineering, Technology & Telecom (SETT), we're passionate about helping you find a job that works for you. How about this one?** We're seeking for a Manager, Quality Assurance Scientist to work in the north region, in PR. With us, it's all about finding the job that's just right. **This job might be an outstanding fit if you have:** + Bachelor Degree in Science (Chemical, Engineering, Biology, Pharmacy or Microbiology) with six (6) years of experience in Quality Assurance responsibilities in a pharmaceutical industry, or Doctoral Degree (PhD) in Pharmacy with valid License in Pharmacy (Good Standing and / or without Restrictions of Puerto Rico Board of Pharmacy). + Knowledge of manufacturing operations of Oral Solid Dosage and Parenteral Products Manufacturing. + Strong knowledge of relevant GMP, FDA, EU regulations and the ability to interpret and apply them for intended use. + Fully bilingual (Spanish/English) communication skills, both written and verbal. + Self-motivated, creative and team work oriented. + Technical and scientific capability to make firm decisions and recommendations. + Excellent interpersonal skills and the ability to interact with people at all levels. Effective communication skills. + Sense of urgency and analytical thinking. + Solid ability for analyzing data detecting deviations, inconsistencies and interpret sampling test results. + Proficient knowledge of problem solving and root cause analysis methodologies (i.e. Kepner Tregoe). + Proficient knowledge of computer systems (Microsoft Office etc.) and applications like Trackwise and SAP. + Willing to work irregular hours, rotative shifts, weekends and holidays when needed. **What happens next** Once you apply, you'll proceed to next steps if your skills and experience look like a good fit. But don't worry-even if this position doesn't work out, you're still in our network. That means all our recruiters will have access to your profile, expanding your opportunities even more. Helping you discover what's next in your career is what we're all about, so let's get to work. Apply today! As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (********************************************************************* for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community. Why Kelly Science & Clinical? Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed. About Kelly Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year. Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

Validation & Engineering Group (VEG) is a leading services supplier provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. Job Description Responsible for performing chemical and physical testing and analysis in accordance with prescribed methods, procedures and regulations. Performs a variety of duties related to the efficient and effective functioning of the laboratory. Performs chemical and physical testing and analysis to raw materials, in-process product, validation samples, special samples, finished goods, and stabilities in accordance with prescribed methods, procedures and regulations. Reports any deviation or suspect result immediately to the laboratory supervisor and collaborates to identify the root cause. Accurately and timely captures and document data. Promptly enters data into respective system. Maintains detailed records in compliance with applicable procedures. Reviews laboratory data for validity and accuracy. Reports any non conformances. Executes validation protocols and documents results. Troubleshoots and maintains laboratory equipment and instruments. Assists with Change Controls. Maintains laboratory supplies and assures adequate inventory. Qualifications Bachelor Degree in Sciences, preferred in Chemistry or Biochemistry Active license preferred,(based on professional experience for the job, Chemical Technology, Biology, Microbiology, and Medical Technology may be considered). This position requires one year of relevant experience in laboratory. Additional Information Positions available for Puerto Rico. Validation and Engineering Group, Inc. is an Equal Employment Opportunity employer.

Validation & Engineering Group (V&EG) is a leading services supplier provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. Job Description Under general direction, functions as the technical specialist for testing & development in areas of molecular biology and microbiology. Focus is on the complex technical issues and scope is typically multi-organizational and/or multi-site and /or involving outside resources. Functions: Responsible for providing technical guidance, Provide reports, data analysis and ensure flow of communication between technical groups including following up on and resolving issues that arise. Resolve technical issues and troubleshoot for assays as necessary, Ensure lab compliance - which includes implementing procedures that enhance GMP, GLP and safety. Manage existing and/or develop and implement new programs, processes and methodologies, Develop, revise and audit various complex controlled documents that may have multi-organizational and/or multi-site impact. Approve lab investigations, Lead audit teams May serve as subject matter expert to develop technical training. May perform routine work in a specific area of responsibility as necessary. Represents the department/organization on various teams, Independently responsible for following through on multi-site action items.. May interact with regulatory agencies regarding area(s) of responsibility including written responses. May resolve issues with outside resources. Performs special projects as requested by supervisor, May supervise employees as necessary to meet technical requirements. Competencies/Skills: Understand, support and demonstrate values. Excellent communication skills, facilitation and presentation skills. Excellent technical writing skills. Strong computer operation skills including work processing, presentation, database and spreadsheet application skills, Excellent project management and organizational skills including the ability to independently understand, follow, implement complex instructions and follow assignments through to completion. Advanced skill in handling multiple responsibilities, tasks and projects simultaneously including ability to shift priorities. Excellent knowledge of and experience with processes involved in quality analytical labs, validation, manufacturing, quality assurance, process development and distribution. Extensive knowledge of all testing including the development and validation of assays and the ability to perform all testing in specific area of responsibility. Knowledge of pharmaceutical processes, Strong knowledge of U.S. regulations and practices pertaining to the testing of pharmaceutical/biological products. Knowledge of basic international regulations and practices pertaining to the testing of pharmaceutical/biological products Extensive knowledge and application of GMPs/CFRs. Ability to evaluate compliance issues. Skill in evaluating and documenting according to Company and various guidelines. Proficient at maintenance, troubleshooting and operation of equipment in area of expertise. Advanced scientific data analysis and interpretation skills. Advanced skills in solving complex problems. Advanced data trending and evaluation. Strong skill in working independently and to effectively interact with various levels. Ability to interact with regulatory agencies both orally and in writing. Initiate, coordinate and lead cross functional teams. Excellent skill in leading, motivating, influencing, and negotiating Qualifications Expertise in Technical Writing, must have written reports for investigations, method transfers/validations, • Root Cause Analysis experience and CAPA identification and implementation • Fully bilingual English/Spanish • Meeting and conference calls facilitator, with multilevel audience (Upper level Management to analysts) • Presentation skills • Oriented to solve problems and troubleshoot, technical proficiency • Simple statistical assessments Doctorate degree in Sciences or Master's degree in Sciences & 3 years of directly related experience or Bachelor's degree in Sciences & 5 years of directly related experience • BS in Chemistry or Biochemistry preferred • Knowledge in TrackWise, CDOCS, Maximo • Knowledge in PowerPoint, Excel, Word, One Note Additional Information Positions available for Puerto Rico. Validation and Engineering Group, Inc. is an Equal Employment Opportunity employer.